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Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance. A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports. Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices. Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.

Centers of excellence and bundled payment models have driven perioperative optimization and surgical site infection (SSI) prevention with decolonization protocols and antibiotic prophylaxis strategies. We sought to evaluate time trends in the incidence of deep SSI and its causative organisms after six orthopaedic procedures in a US-based integrated healthcare system.We conducted a population-level time-trend study using data from Kaiser Permanente's orthopaedic registries. All patients who underwent primary anterior cruciate ligament reconstruction (ACLR), total knee arthroplasty (TKA), elective total hip arthroplasty (THA), hip fracture repair, shoulder arthroplasty, and spine surgery were identified (2009 to 2020). The annual incidence of 90-day deep SSI was identified according to the National Healthcare Safety Network/Centers for Disease Control and Prevention guidelines with manual chart validation for identified infections. Poisson regression was used to evaluate annual trends in SSI incidence with surgical year as the exposure of interest. Annual trends in overall incidence and organism-specific incidence were considered.The final study sample was composed of 465,797 primary orthopaedic procedures. Over the 12-year study period, a decreasing trend in deep SSI was observed for ACLR and hip fracture repair. Although there was variation in incidence rates for specific operative years for TKA, elective THA, shoulder arthroplasty, and spine surgery, no consistent decreasing trends over time were found. Decreasing rates of Staphylococcus aureus infections over time after hip fracture repair, shoulder arthroplasty, and spine surgery and decreasing trends in antibiotic resistance after elective THA and spine surgery were also observed. Increasing trends of polymicrobial infections were observed after TKA and Cutibacterium acnes after elective THA.The overall incidence of deep SSI after six orthopaedic procedures was rare. Decreasing SSI rates were observed for ACLR and hip fracture repair within our US-based healthcare system. Polymicrobial infections after TKA and Cutibacterium acnes after elective THA warrant closer surveillance.IV.

Background With the heightened focus on lowering adverse postoperative events through preoperative patient optimization, malnutrition may be a modifiable risk factor that could be addressed and lead to improved postoperative outcomes. However, an understanding of the association between malnutrition status and adverse postoperative events following shoulder arthroplasty is lacking. We sought to evaluate the association between preoperative malnutrition status, identified via the total serum lymphocyte count, and adverse postoperative events following shoulder arthroplasty. Methods We conducted a cohort study using data from Kaiser Permanente's Shoulder Arthroplasty Registry. Patients who underwent elective primary shoulder arthroplasty were identified (2005-2016). Patients with a preoperative total lymphocyte count Results The final study cohort comprised 6956 shoulder arthroplasty patients, with 2133 (30.7%) identified as malnourished. No difference in septic or aseptic revision risks was observed when comparing patients with and without malnutrition; however, malnourished patients had a higher risk for death, regardless of age ( Conclusion Only a higher mortality risk was observed to be associated with total lymphocyte count-defined malnutrition in patients undergoing elective shoulder arthroplasty. When instead looking at total lymphocyte count continuously, an optimal threshold for discriminating risk of adverse postoperative events could not be identified. Further study is needed to identify an appropriate indicator of malnutrition in shoulder arthroplasty patients and if this indicator can be modified to improve patient status and quality of care. Level of Evidence Level III; Retrospective Cohort Comparative Study

Background The total joint literature has shown promising results of bisphosphonate use on decreasing early bone loss after hip and knee arthroplasty and reducing aseptic revision risk though a higher risk of periprosthetic fracture has also been reported. We sought to evaluate the association between bisphosphonate use and aseptic revision risk in patients undergoing shoulder arthroplasty. Methods A US integrated healthcare system's registry was used to identify 6204 patients who underwent primary elective shoulder arthroplasty for osteoarthritis (2005-2016). Preoperative bisphosphonate users (defined as having at ≥6-month supply and 80% adherence) were compared to nonbisphosphonate users. Multivariable Cox proportional hazard regression was used to evaluate aseptic revision risk according to bisphosphonate use while adjusting for confounders. Secondary analysis stratified by age (40-64, ≥65 years) and bone quality status (normal, osteopenia, osteoporosis, or unknown). Results At the time of index procedure, 564 (9.1%) were considered as bisphosphonate users. We failed to observe a difference in aseptic revision risk by bisphosphonate use (hazard ratio = 0.92, 95% confidence interval = 0.50-1.72). No association was observed even after stratifying by bone quality and age. No revisions for periprosthetic fracture occurred in the bisphosphonate user group during follow-up. Conclusions While prior studies in lower extremity joint arthroplasty cohorts have observed a differential risk for revision surgery with bisphosphonate use, we failed to observe any associations between bisphosphonate use and revision risk in a cohort of shoulder arthroplasty patients. Level of Evidence Level III; Retrospective Cohort Comparative Study

Background: Polyetheretherketone (PEEK) rods were clinically introduced in the mid-2000s as an alternative to titanium (Ti) rods for posterior instrumented lumbar spine fusion, theorized to reduce the risk of adjacent segment disease (ASD). However, few studies have follow-up beyond 2 years. Consequently, we conducted a matched cohort study using data from Kaiser Permanente9s spine registry to compare the 2 rod systems and risk for outcomes. Methods: Patients aged ≥18 undergoing first posterior lumbar fusion for a degenerative diagnosis from 2009 to 2018 using either a PEEK or a Ti rod were identified. Fusions using Ti rods were 2:1 propensity score matched to PEEK rods on the following factors: patient age, body mass index, smoking, American Society of Anesthesiologists classification, diagnosis, interbody use, bone morphogenic protein use, number of levels fused, fusion levels, and operative year. The matched sample included 154 PEEK and 308 Ti fusions. We used Cox regression to evaluate ASD and nonunion, and logistic regression to evaluate 90-day emergency department (ED) visit, readmission, and complication. Results: We did not observe a difference in risk for ASD (hazard ratio = 1.02, 95% confidence interval [CI] = 0.66–1.59) or ED visit (odds ratio [OR] = 0.88, 95% CI = 0.48–1.59). A lower likelihood of readmission (OR = 0.34, 95% CI = 0.13–0.94) was observed following PEEK fusion compared with Ti. No nonunions or 90-day complications were observed for the PEEK group; 5 (2-year cumulative incidence = 0.7%) nonunions and 4 (1.3%) complications were observed for the Ti group. Conclusions: Our multicenter study did not support the hypothesis that PEEK rods are associated with a lower ASD risk. Reasons for readmission need to be identified to better understand the differences observed here. Further study of patients with TLIF using Ti and PEEK rods and posterolateral fusion with Ti and PEEK rods is needed. Clinical Relevance: The present study adds to the literature supporting their midterm effectiveness of PEEK rods compared with Ti rods for both their safety and their effectiveness at the 5–7-year follow-up. Level of Evidence: 3.

Background Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. Study design Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. Results Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). Conclusions The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Background and purpose — A challenge comparing outcomes from total hip arthroplasty between countries is variation in preoperative characteristics, particularly comorbidity. Therefore, we investigated between-country variation in comorbidity in patients based on ASA class distribution, and determined any variation of ASA class to mortality risk between countries.\ud \ud \ud Patients and methods — All arthroplasty registries collecting ASA class and mortality data in patients with elective primary THAs performed 2012–2016 were identified. Survival analyses of the influence of ASA class on 1-year mortality were performed by individual registries, followed by meta-analysis of aggregated data.\ud \ud \ud Results — 6 national registries and 1 US healthcare organization registry with 418,916 THAs were included. There was substantial variation in the proportion of ASA class III/IV, ranging from 14% in the Netherlands to 39% in Finland. Overall, 1-year mortality was 0.93% (95% CI 0.87–1.01) and increased from 0.2% in ASA class I to 8.9% in class IV. The association between ASA class and mortality measured by hazard ratios (HR) was strong in all registries even after adjustment for age and sex, which reduced them by half in all registries. Combined adjusted HRs were 2.0, 6.1, and 22 for ASA class II–IV vs. I, respectively. Associations were moderately heterogeneous across registries.\ud \ud \ud Interpretation — We observed large variation in ASA class distribution between registries, possibly explained by differences in background morbidity and/or international variation in access to surgery. The similar, strong mortality trends by ASA class between countries enhance the relevance of its use as an indicator of comorbidity in international registry studies.

BACKGROUND: Dual-mobility cups in THA were designed to reduce prosthesis instability and the subsequent risk of revision surgery in high-risk patients, such as those with hip fractures. However, there are limited data from clinical studies reporting a revision benefit of dual-mobility over conventional THA. Collaboration between anthroplasty registries provides an opportunity to describe international practice variation and compare between-country, all-cause revision rates for dual-mobility and conventional THA. QUESTIONS/PURPOSES: We summarized observational data from multiple arthroplasty registries for patients receiving either a dual-mobility or conventional THA to ask: (1) Is dual-mobility use associated with a difference in risk of all-cause revision surgery compared with conventional THA? (2) Are there specific patient characteristics associated with dual-mobility use in the hip fracture population? (3) Has the use of dual-mobility constructs changed over time in patients receiving a THA for hip fracture? METHODS: Six member registries of the International Society of Arthroplasty Registries (from Australia, Denmark, Sweden, the Netherlands, the United Kingdom, and the United States) provided custom aggregate data reports stratified by acetabular cup type (dual-mobility or conventional THA) in primary THA for hip fracture between January 1, 2002, and December 31, 2019; surgical approach; and patient demographic data (sex, mean age, American Society of Anesthesiologists class, and BMI). The cumulative percent revision and mortality were calculated for each registry. To determine a global hazard ratio of all-cause revision for dual-mobility compared with conventional THA designs, we used a pseudoindividual patient data approach to pool Kaplan-Meier prosthesis revision data from each registry and perform a meta-analysis. The pseudoindividual patient data approach is a validated technique for meta-analysis of aggregate time-to-event survival data, such as revision surgery, from multiple sources. Data were available for 15,024 dual-mobility THAs and 97,200 conventional THAs performed for hip fractures during the study period. RESULTS: After pooling of complete Kaplan-Meier survival data from all six registries, the cumulative percent revision for conventional THA was 4.3% (95% confidence interval [CI] 4.2% to 4.5%) and 4.7% (95% CI 4.3% to 5.3%) for dual-mobility THA at 5 years. We did not demonstrate a lower risk of all-cause revision for patients receiving dual-mobility over conventional THA designs for hip fracture in the meta-analysis once between-registry differences were adjusted for (HR 0.96 [95% CI 0.86 to 1.06]). A lower proportion of dual-mobility procedures were revised for dislocation than conventional THAs (0.9% versus 1.4%) but a higher proportion were revised for infection (1.2% versus 0.8%). In most registries, a greater proportion of dual-mobility THA patients were older, had more comorbidities, and underwent a posterior approach compared with conventional THA (p < 0.001). The proportion of dual-mobility THA used to treat hip fractures increased in each registry over time and constituted 21% (2438 of 11,874) of all THA procedures in 2019. CONCLUSION: The proportion of dual-mobility THAs in patients with hip fractures increased over time, but there was large variation in use across countries represented here. Dual-mobility cups were not associated with a reduction in the overall risk of revision surgery in patients with hip fractures. A randomized controlled trial powered to detect the incidence of dislocation and subsequent revision surgery is required to clarify the efficacy of dual-mobility cups to treat hip fractures. LEVEL OF EVIDENCE: Level III, therapeutic study.

Background and purpose ��� Studies describing time-related change in reasons for knee replacement revision have been limited to single regions or institutions, commonly analyze only 1st revisions, and may not reflect true caseloads or findings from other areas. We used revision procedure data from 3 arthroplasty registries to determine trends and differences in knee replacement revision diagnoses. Patients and methods ��� We obtained aggregated data for 78,151 revision knee replacement procedures recorded by the Swedish Knee Arthroplasty Register (SKAR), the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), and the Kaiser Permanente Joint Replacement Registry (KPJRR) for the period 2003���2017. Equivalent diagnosis groups were created. We calculated the annual proportions of the most common reasons for revision. Results ��� Infection, loosening, and instability were among the 5 most common reasons for revision but magnitude and ranking varied between registries. Over time there were increases in proportions of revisions for infection and decreases in revisions for wear. There were inconsistent proportions and trends for the other reasons for revision. The incidence of revision for infection showed a uniform increase. Interpretation ��� Despite some differences in terminology, comparison of registry-recorded revision diagnoses is possible, but defining a single reason for revision is not always clear-cut. There were common increases in revision for infection and decreases in revision for wear, but variable changes in other categories. This may reflect regional practice differences and therefore generalizability of studies regarding reasons for revision is unwise.

Introduction Anatomic total shoulder arthroplasty (TSA) is a proven treatment for glenohumeral joint osteoarthritis, with superior results compared with hemiarthroplasty. However, glenoid component loosening remains a problem and is one of the most common causes of failure in TSA. Multiple component designs have been developed in an attempt to reduce loosening rates. The purpose of this study was to evaluate risk of revision after anatomic TSA according to the glenoid component design. Methods We conducted a cohort study including patients aged ≥18 years who underwent primary elective TSA for the diagnosis of osteoarthritis between 2010 and 2017. Patients with missing implant information, who received stemless humeral implants, or who received augmented glenoid implants, were excluded. Glenoid component designs used were categorized into 4 mutually exclusive treatment groups: polyethylene central-pegged ingrowth, polyethylene-metal hybrid, polyethylene all-cemented pegged, and polyethylene cemented keeled. Multivariable competing risk regression was used to evaluate the risk of glenoid loosening as a cause-specific revision by the glenoid component design. Results Of the 5566 TSA included in the final cohort, 39.2% of glenoid implants were polyethylene central-pegged ingrowth, 31.1% were polyethylene-metal hybrid, 26.0% were polyethylene all-cemented pegged, and 3.6% were polyethylene cemented keeled. At 6-year final follow-up, 4.1% of TSA were revised for any cause, and 1.4% for glenoid loosening. Compared with the polyethylene central-pegged ingrowth design, no difference in glenoid loosening revision risk was observed for the polyethylene-metal hybrid design (hazard ratio [HR] = 1.15, 95% confidence interval [CI] = 0.42-3.20). However, both the polyethylene all-cemented pegged (HR = 2.48, 95% CI = 1.08-5.66) and polyethylene cemented keeled (HR = 3.84, 95% CI = 1.13-13.00) designs had higher risks for revision due to glenoid loosening. Conclusions We observed glenoid component designs to be associated with differential risks in revision due to glenoid loosening with polyethylene all-cemented pegged glenoids and polyethylene cemented keeled glenoids having higher risks when compared with polyethylene central-pegged ingrowth glenoids. Surgeons may want to consider the glenoid component design when performing anatomic TSA.

Background The efficacy of commercially available antibiotic-loaded bone cement (ABC) in preventing infection in total knee arthroplasty (TKA) is unclear. We sought to determine the effectiveness of commercially available ABC in reducing the risk of infection following TKA, both overall and among 3 subgroups of patients with a higher risk of infection (diabetes, body mass index ≥35 kg/m, and American Society of Anesthesiologists classification ≥3), and to evaluate the association between the use of ABC and the risks of aseptic revision and revision for aseptic loosening. Methods The Kaiser Permanente Total Joint Replacement Registry was utilized to evaluate 87,018 primary cemented TKAs performed from 2008 to 2016. The primary outcome was time to infection (90-day deep infection or septic revision). Reduced infection risk with ABC relative to regular cement was tested with use of propensity-score-weighted Cox proportional-hazards models with superiority and noninferiority testing. All analyses were replicated for each of the 3 high-risk subgroups. For the secondary revision outcomes, propensity-score-weighted Cox proportional-hazards models were utilized. Results Regular cement was found to be noninferior to ABC with respect to risk infection (hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.93 to 1.40) and cost across all TKA patients. However, a lower risk of infection was observed with ABC among TKA patients with diabetes (HR, 0.72; 95% CI, 0.52 to 0.99). There was no evidence of a difference in risk of revision for ABC compared with regular cement. Conclusions We found that the additional cost associated with the use of commercially prepared ABC in primary TKA was not justified in all patients; however, the risk of reduction was lower among patients with diabetes who received ABC. Further study is warranted to identify the efficacy of ABC among other high-risk populations. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background and purpose — Rates of knee replacement (KR) are increasing worldwide. Based on population and practice changes, there are forecasts of a further exponential increase in primary knee replacement through to 2030, and a corresponding increase in revision knee replacement. We used registry data to document changes in KR over the past 15 years, comparing practice changes across Sweden, Australia, and the United States. This may improve accuracy of future predictions. Patients and methods — Aggregated data from the Swedish Knee Arthroplasty Register (SKAR), the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), and the Kaiser Permanente Joint Replacement Registry (KPJRR) were used to compare surgical volume of primary and revision KR from 2003 to 2017. Incidence was calculated using population census statistics from Statistics Sweden and the Australian Bureau of Statistics, as well as the yearly active membership numbers from Kaiser Permanente. Further analysis of KR by age < 65 and ≥ 65 years was carried out. Results — All registries recorded an increase in primary and revision KR, with a greater increase seen in the KPJRR. The rate of increase slowed during the study period. In Sweden and Australia, there was a smaller increase in revision surgery compared with primary procedures. There was consistency in the mean age at surgery, with a steady small decrease in the proportion of women having primary KR. The incidence of KR in the younger age group remained low in all 3 registries, but the proportional increases were greater than those seen in the ≥ 65 years of age group. Interpretation — There has been a generalized deceleration in the rate of increase of primary and revision KR. While there are regional differences in KR incidence, and rates of change, the rate of increase does not seem to be as great as previously predicted.

Background The impact of prior lumbar spinal fusion on the change in physical activity level following total hip arthroplasty (THA) has not been thoroughly examined. Therefore, we sought to compare the change in physical activity level following THA for patients with and without a history of lumbar spine fusion. Methods Patients who underwent primary elective THA were identified using an integrated healthcare system’s Total Joint Replacement Registry (2010-2013). Prior lumbar spine fusion was identified using the healthcare system’s Spine Registry. Physical activity was self-reported by patients and measured in min/wk. Generalized linear models were used to evaluate the association between prior spine fusion and the change in physical activity from 1 year pre-THA to 1-2 years post-THA. Results Of 11,416 THAs, 90 (0.8%) had a history of lumbar spinal fusion. Patients with a prior lumbar fusion had a median physical activity level of 28 min/wk prior to THA compared to 45 min/wk in the patients with no history of lumbar spinal fusion. One year after THA, patients with a history of lumbar spinal fusion reported a median of 120 min/wk of physical activity compared to 150 min/wk for patients without a history of lumbar spinal fusion. The difference in physical activity level change between groups was not statistically significant (estimate = −23.1, 95% confidence interval −62.1 to 15.9, P = .246). Conclusion Patients with prior lumbar fusion were found to have lower self-reported physical activity levels than patients without spine fusion both before and after THA surgery. However, both groups saw the same degree of improvement in physical activity level following THA. These findings may help in counseling patients who have had a prior lumbar spine fusion and in setting appropriate expectations prior to THA.

Previous studies have documented racial and ethnic disparities in total joint arthroplasty (TJA) utilization in the United States. A potential mediator of healthcare disparities is unequal access to care, and studies have suggested that disparities may be ameliorated in systems of universal access. The purpose of this study was to assess whether racial/ethnic disparities in TJA utilization persist in a universally insured population of patients enrolled in a managed healthcare system.This retrospective cohort study used data from a US integrated healthcare system (2015 to 2019). Patients aged 50 years and older with a diagnosis of hip or knee osteoarthritis were included. The outcome of interest was utilization of primary total hip arthroplasty and/or total knee arthroplasty, and the exposure of interest was race/ethnicity. Incidence rate ratios (IRRs) were modeled using multivariable Poisson regression controlling for confounders.There were 99,548 patients in the hip analysis and 290,324 in the knee analysis. Overall, 10.2% of the patients were Black, 20.5% were Hispanic, 9.6% were Asian, and 59.7% were White. In the multivariable analysis, utilization of primary total hip arthroplasty was significantly lower for all minority groups including Black (IRR, 0.55, 95% confidence interval [CI], 0.52-0.57, P0.0001), Hispanic (IRR, 0.63, 95% CI, 0.60-0.66, P0.0001), and Asian (IRR, 0.64, 95% CI, 0.61-0.68, P0.0001). Similarly, utilization of primary total knee arthroplasty was significantly lower for all minority groups including Black (IRR, 0.52, 95% CI, 0.49-0.54, P0.0001), Hispanic (IRR, 0.72, 95% CI, 0.70-0.75, P0.0001), and Asian (IRR, 0.60, 95% CI, 0.57-0.63, P0.0001) (all in comparison with White as reference).In this study of TJA utilization in a universally insured population of patients enrolled in a managed healthcare system, disparities on the basis of race and ethnicity persisted. Additional research is required to determine the reasons for this finding and to identify interventions which could ameliorate these disparities.

Background and purpose: Characteristics of patients receiving total knee arthroplasty (TKA) and prostheses used vary between regions and change with time. How these practice variations influence revision remains unclear. We combined registry data for better understanding of the impact of variation, which could potentially improve revision rates. Patients and methods: We used data from 2003 to 2019 for primary TKA from arthroplasty registries of Sweden (SKAR), Australia (AOANJRR), and Kaiser Permanente (KPJRR). We included 1,072,924 TKA procedures for osteoarthritis. Factors studied included age, sex, ASA class, BMI category, prosthesis constraint, fixation, bearing mobility, patellar resurfacing, and polyethylene type. Cumulativepercentage revision (CPR) was calculated using Kaplan–Meier estimates, and unadjusted Cox hazard ratios were used for comparisons. Random-effects generic inverse-variance meta-analytic methods were used to determine summary effects. Results: We found similarities in age and sex, but between-registry differences occurred in the other 7 factors studied. Patients from Sweden had lower BMI and ASA scores compared with other registries. Use of cement fixation was similar in the SKAR and KPJRR, but there were marked differences in patellar resurfacing and posterior stabilized component use. Meta-analysis results regarding survivorship favored patients aged ≥ 65 years and minimally stabilized components. There were inconsistent results with time for sex, fixation, and bearing mobility, and no differences for the patellar resurfacing or polyethylene type comparisons. Interpretation: Marked practice variation was found. Use of minimally stabilized and possibly also cemented and fixed bearing prostheses is supported.

ObjectivesGenerating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.Design, setting, and participantsWe invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.Main outcome measuresConsensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.ResultsOf 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.ConclusionsWe have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

Background Although safety in same-day discharge total joint arthroplasty (TJA) has been reported, findings are limited to healthier patients, specific surgeons, and/or specific institutions. Indications for same-day discharge TJA have expanded to include patients with multiple comorbidities; however, safety in this specific patient population remains unknown. Therefore, we sought to compare the risk of 90-day adverse events in higher-risk patients undergoing same-day discharge versus inpatient TJA. Methods The Kaiser Permanente Total Joint Replacement Registry was utilized to conduct a cohort study. All patients with an American Society of Anesthesiologists (ASA) classification of ≥3 who underwent primary elective TJA for osteoarthritis from 2017 through 2018 were identified. The risk of 90-day adverse events (i.e., emergency department visits, unplanned readmissions, complications, and mortality) was evaluated with use of propensity score-weighted Cox proportional hazard regression including noninferiority testing with a margin of 1.10. Results The cohort included a total of 5,250 patients who underwent total hip arthroplasty and 9,752 patients who underwent total knee arthroplasty, of whom 1,742 (33.2%) and 3,283 (33.7%) had same-day discharge, respectively. Same-day discharge hip arthroplasty was noninferior to an inpatient stay in terms of emergency department visits (hazard ratio [HR], 0.73; 1-sided HR 95% upper bound [UB], 0.84), readmissions (HR, 0.47; 95% UB, 0.61), and complications (HR, 0.63; 95% UB, 0.75); we did not have evidence of noninferiority for mortality (HR, 0.84; 95% UB, 1.97). Same-day discharge knee arthroplasty was noninferior to an inpatient stay in terms of emergency department visits (HR, 0.79; 95% UB, 0.87), readmission (HR, 0.80; 95% UB, 0.95), complications (HR, 0.72; 95% UB, 0.82), and mortality (HR, 0.53; 95% UB, 1.03). Conclusions We found that same-day discharge TJA did not increase the risk of emergency department visits, unplanned readmissions, and complications compared with an inpatient stay for higher-risk patients, suggesting that it is possible to expand indications for same-day discharge TJA in the hospital setting while maintaining safety. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

BACKGROUND Prior studies have documented racial and ethnic disparities in total hip arthroplasty (THA) outcomes in the U.S. The purpose of this study was to assess whether racial/ethnic disparities in THA outcomes persist in a universally insured population of patients enrolled in an integrated health-care system. METHODS A U.S. health-care system total joint replacement registry was used to identify patients who underwent elective primary THA between 2001 and 2016. Data on patient demographics, surgical procedures, implant characteristics, and outcomes were obtained from the registry. The outcomes analyzed were lifetime revision (all-cause, aseptic, and septic) and 90-day postoperative events (infection, venous thromboembolism, emergency department [ED] visits, readmission, and mortality). Racial/ethnic differences in outcomes were analyzed with use of multiple regression with adjustment for socioeconomic status and other potential confounders. RESULTS Of 72,755 patients in the study, 79.1% were white, 8.2% were black, 8.5% were Hispanic, and 4.2% were Asian. Compared with white patients, lifetime all-cause revision was lower for black (adjusted hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66 to 0.94; p = 0.007), Hispanic (adjusted HR, 0.73; 95% CI, 0.61 to 0.87; p = 0.002), and Asian (adjusted HR, 0.49; 95% CI, 0.37 to 0.66; p < 0.001) patients. Ninety-day ED visits were more common among black (adjusted odds ratio [OR], 1.15; 95% CI, 1.05 to 1.25; p = 0.002) and Hispanic patients (adjusted OR, 1.18; 95% CI, 1.08 to 1.28; p < 0.001). For all other postoperative events, minority patients had similar or lower rates compared with white patients. CONCLUSIONS In contrast to prior research, we found that minority patients enrolled in a managed health-care system had rates of lifetime reoperation and 90-day postoperative events that were generally similar to or lower than those of white patients, findings that may be related to the equal access and/or standardized protocols associated with treatment in the managed care system. However, black and Hispanic patients still had higher rates of 90-day ED visits. Further research is required to determine the reasons for this finding and to identify interventions that could reduce unnecessary ED visits. LEVEL OF EVIDENCE Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background We evaluated anatomic total shoulders undergoing early revision (less than two years) in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the Kaiser Permanente Shoulder Arthroplasty Registry (KPSAR). Methods A cross-sectional comparison of both registries was performed between the years of 2009 and 2012. Only patients who underwent anatomic total shoulder arthroplasty for a primary diagnosis of osteoarthritis were included. Aggregate-level data of patients undergoing early revisions done within two years of index arthroplasty were evaluated, and descriptive analysis was conducted. Results During the study period, 4614 patients were identified in the AOANJRR compared to 2036 in the KPSAR. Rotator cuff pathology, component loosening, and prosthetic instability were among the most common reasons for revision in both registries. A higher rate of revision in the AOANJRR was found to be secondary to the failure of one specific prosthesis, which has since been discontinued Discussion Comparing reasons for early revision in total shoulder arthroplasty revealed several similarities between the AOANJRR and KPSAR. Differences were also noted, and this study served to highlight the importance prosthesis selection can play in determining outcomes. Cooperation among registries may allow for earlier identification of risk factors for failure in shoulder arthroplasty.

BACKGROUND Prior studies have identified diabetes and disease severity (defined using hemoglobin A1c [HbA1c]) as potential risk factors for complications after shoulder arthroplasty. Evaluations of diabetes status and risk of adverse outcomes beyond the 30-day window either are limited or have not accounted for disease severity. Further, measures of diabetes severity other than HbA1c have yet to be investigated in a shoulder arthroplasty population. QUESTIONS/PURPOSES (1) Are diabetes status and glycemic control associated with adverse events, including deep infection, all-cause revision, and 90-day readmission after shoulder arthroplasty? (2) Is postoperative HbA1c associated with revision risk? (3) Is there a threshold of preoperative HbA1c that best identifies patients with diabetes who are at higher risk of 3-year deep infection, 1-year all-cause revision, or 90-day readmission? (4) Can the Adapted Diabetes Complications Severity index (aDCSI) be used as an alternative measure of diabetes severity in evaluating the risk of deep infection, all-cause revision, and 90-day readmission and identification of patients with diabetes at higher risk for these events? (5) Is there a difference between elective and traumatic shoulder arthroplasty patients? METHODS We conducted a retrospective registry-based cohort study using Kaiser Permanente's Shoulder Arthroplasty Registry (2005-2015). Primary shoulder arthroplasties were classified as patients with and without diabetes. Patients with diabetes were further evaluated using two disease severity measures (1) HbA1c, with good glycemic control classified as preoperative HbA1c < 7.0% and poor control defined as HbA1c ≥ 7.0%; and (2) aDCSI, classified as mild (score of 0-2) or severe (score ≥ 3) diabetes. Cox regression was used to evaluate the risk of deep infection and revision according to diabetes status and disease severity; conditional logistic regression was used for 90-day readmission. Time-dependent 1-year postoperative HbA1c was used to evaluate revision risk in Cox regression. All models were adjusted for covariates and stratified by elective versus trauma shoulder arthroplasty. Receiver operating characteristic curves were generated for HbA1c and aDCSI to determine whether a threshold exists to identify patients at higher risk of deep infection, all-cause revision, or 90-day readmission. The study sample consisted of 8819 patients; 7353 underwent elective shoulder arthroplasty and 1466 underwent shoulder arthroplasty due to trauma. For elective shoulder arthroplasty, 1430 patients (19%) had diabetes, and among the patients who underwent arthroplasty due to trauma, 444 (30%) had diabetes. RESULTS Patients with diabetes who underwent elective shoulder arthroplasty and had poor glycemic control had a higher likelihood of 90-day readmission compared with patients without diabetes (OR, 1.5; 95% CI, 1.0-2.1; p = 0.032). No association was found for patients with diabetes who underwent shoulder arthroplasty due to trauma. No association was found between postoperative HbA1c and revision risk. Receiver operating characteristic curve analysis suggested preoperative HbA1c performed poorly at differentiating adverse events. When using aDCSI, patients with severe diabetes who underwent both elective and traumatic shoulder arthroplasty had a higher likelihood of 90-day readmission compared with patients without diabetes (OR, 1.6; 95% CI, 1.2-2.2; p = 0.001 and OR, 1.8; 95% CI, 1.2-2.7; p = 0.005, respectively). Similar to HbA1c, the aDCSI was a poor classifier in differentiating adverse events. CONCLUSIONS Of the longer-term outcomes evaluated, more-severe diabetes was only found to be associated with an increase in 90-day readmissions after shoulder arthroplasty; a stronger association was found when using the aDCSI in identifying diabetes severity. Arbitrary cutoffs in HbA1c may not be the best method for determining risk of postoperative outcomes. Future work investigating perioperative diabetes management should work to identify and validate measures, such as the aDCSI, that better identify patients at higher risk for postoperative outcomes and, more importantly, whether outcomes can be improved by modifying these measures with targeted interventions. LEVEL OF EVIDENCE Level III, therapeutic study.

Although noncemented hemiarthroplasty has been associated with a higher risk of revision surgery as compared with cemented fixation, it remains uncertain whether this increased risk applies to all noncemented stem design types or only a subset. The purpose of this study was to assess the risk of aseptic revision associated with three common types of noncemented stem designs as compared with cemented fixation in the hemiarthroplasty treatment of femoral neck fractures in the elderly patients.This was a retrospective cohort study of patients aged 60 years and older who sustained a hip fracture and underwent hemiarthroplasty between 2009 and 2018 at one of 35 hospitals owned by a large US health maintenance organization. Hemiarthroplasty fixation was categorized as cemented or noncemented, with the noncemented stems further classified as single wedge without collar, fit and fill without collar, or fit and fill with collar. The primary outcome was aseptic revision, and the median follow-up time was 4.8 years.Of 12,071 patients who underwent hemiarthroplasty during the study period (average age 82.0 ± 8.4 years, 67.9% women), 807 (6.7%) received a single-wedge stem without collar, 2,124 (17.6%) received a fit-and-fill stem without collar, 2,453 (20.3%) received a fit-and-fill stem with collar, and 6,687 (55.4%) received a cemented stem. Compared with cemented fixation, all the noncemented stem design types were associated with a markedly higher risk of aseptic revision in the multivariable analysis, including single wedge without collar (hazard ratio [HR] 2.00, 95% confidence interval [CI], 1.38 to 2.89, P0.001), fit and fill without collar (HR 1.52, 95% CI, 1.14 to 2.04, P = 0.005), and fit and fill with collar (HR 2.11, 95% CI, 1.63 to 2.72, P0.001).In the hemiarthroplasty treatment of elderly patients with hip fracture, all routinely used noncemented stem design types were associated with a higher risk of aseptic revision as compared with cemented fixation.

Background Although the COVID-19 pandemic has disrupted elective shoulder arthroplasty throughput, traumatic shoulder arthroplasty procedures are less apt to be postponed. We sought to evaluate shoulder arthroplasty utilization for fracture during the COVID-19 pandemic and California's associated shelter-in-place order compared to historical controls. Methods We conducted a cohort study with historical controls, identifying patients who underwent shoulder arthroplasty for proximal humerus fracture in California using our integrated electronic health record. The time period of interest was following the implementation of the statewide shelter-in-place order: March 19, 2020-May 31, 2020. This was compared to three historical periods: January 1, 2020-March 18, 2020, March 18, 2019-May 31, 2019, and January 1, 2019-March 18, 2019. Procedure volume, patient characteristics, in-hospital length of stay, and 30-day events (emergency department visit, readmission, infection, pneumonia, and death) were reported. Changes over time were analyzed using linear regression adjusted for usual seasonal and yearly changes and age, sex, comorbidities, and postadmission factors. Results Surgical volume dropped from an average of 4.4, 5.2, and 2.6 surgeries per week in the historical time periods, respectively, to 2.4 surgeries per week after shelter-in-place. While no more than 30% of all shoulder arthroplasty procedures performed during any given week were for fracture during the historical time periods, arthroplasties performed for fracture was the overwhelming primary indication immediately after the shelter-in-place order. More patients were discharged the day of surgery (+33.2%, P = .019) after the shelter-in-place order, but we did not observe a change in any of the corresponding 30-day events. Conclusions The volume of shoulder arthroplasty for fracture dropped during the time of COVID-19. The reduction in volume could be due to less shoulder trauma due to shelter-in-place or a change in the indications for arthroplasty given the perceived higher risks associated with intubation and surgical care. We noted more patients undergoing shoulder arthroplasty for fracture were safely discharged on the day of surgery, suggesting this may be a safe practice that can be adopted moving forward. Level of Evidence Level III; Retrospective Case-control Comparative Study

Discharging patients the same day they have a hip or knee replacement has complication rates, return-to-care measures, and patient experience results that are as good as or better than overnight-ho...

Background Modular tibial stem extensions in total knee arthroplasty (TKA) are designed to reduce the risk of aseptic loosening of the tibial base plate. However, these implants add significant cost and an evaluation of their effectiveness in reducing this risk of loosening has not been studied in a large cohort. We sought to evaluate modular tibial stem utilization in primary TKA. Methods We conducted a cohort study using our integrated healthcare system’s Total Joint Replacement Registry. Patients who underwent cemented primary TKA were identified (2009-2019). Propensity scores were used to 1:1 match patients without to those with a stem extension. Cox proportional-hazards regression was used to evaluate the risk for revision due to aseptic loosening. Results Ten thousand four hundred seventy six TKA with a modular tibial stem were matched to 10,476 TKA without a tibial stem. Stem utilization associated with a lower risk of revision for loosening across all postoperative follow-up (hazard ratio = 0.38, 95% confidence interval = 0.17-0.85). Conclusion In a matched cohort study, we observed presence of a stem extension was associated with a lower risk of revision for aseptic loosening. Further study to identify specific risk factors for aseptic loosening and confirm the findings presented here are warranted. Level of Evidence Level III.

Introduction We sought to identify the incidence of new 90-day cardiac events, 90-day mortality, 90-day unplanned readmissions, and 30-day emergency department (ED) visits after total joint arthroplasty (TJA) in patients with a history of a cardiac implantable electronic device (CIED) and compare these outcomes in TJA patients without a CIED. Methods Kaiser Permanente's Cardiac Device and Total Joint Replacement Registries were used to identify elective primary TJA performed for osteoarthritis. TJA with a CIED was matched with TJA without a CIED (n = 365 pairs) on patient characteristics, demographics, and procedure type. A McNemar test was used to evaluate categorical outcomes. Results Of the TJA with a CIED, there were 24 cardiac events (6.6%), 1 mortality (0.3%), 30 readmissions (8.2%), and 39 ED visits (10.7%). TJA patients with a CIED had a higher likelihood of cardiac events (odds ratio [OR] = 3.14, 95% confidence interval [CI] = 1.28 to 8.08). No difference was observed in mortality (OR = 0.50, 95% CI = 0.02 to 6.98), readmissions (OR = 1.26, 95% CI = 0.71 to 2.25), or ED visits (OR = 1.15, 95% CI = 0.71 to 1.88). Conclusion In our matched cohort study, TJA patients with a history of a CIED had a higher likelihood of incident 90-day cardiac events when compared with patients without a CIED without a difference observed for 90-day mortality, unplanned readmission, and 30-day ED visit. Level of evidence Level III.

Context Prior studies regarding indications for long vs short cephalomedullary nails in the treatment of intertrochanteric fractures had limited sample sizes and follow-up, suggesting a need for further investigation. Objective To evaluate the association between cephalomedullary nail length and outcomes for the treatment of intertrochanteric femur fractures. Design Cohort study using Kaiser Permanente's Hip Fracture Registry. A total of 5526 patients who underwent surgical treatment with cephalomedullary nails for an intertrochanteric femur fracture (2009-2014) were identified: 3108 (56.2%) with long nails and 2418 (43.8%) with short nails. Cox proportional hazards model regression was used to evaluate risks of all-cause revision and revision for periprosthetic fracture. Linear regression was used to evaluate operative time, estimated blood loss, and length of stay. Propensity score weights were used in all models to balance nail groups on patient and device characteristics. Main outcome measures All-cause revision surgery. Results No association was found in risk of all-cause revision (hazard ratio = 0.75, 95% confidence interval [CI] = 0.48-1.15) or revision for periprosthetic fracture (hazard ratio = 0.59, 95% CI = 0.23-1.48) for long nails compared with short nails. Use of longer nails resulted in 18.80 more minutes of operative time (95% CI = 17.33-20.27 minutes), 41.10 mL more of estimated blood loss (95% CI = 31.71-50.48 mL), and a longer hospitalization (8.4 hours; β = 0.35, 95% CI = 0.12-0.58 hours). Conclusion These findings suggest that routine use of short cephalomedullary nails is safe and effective in the treatment of intertrochanteric fractures.

The opioid epidemic remains a serious issue in the United States with significant impact to the medical and socioeconomic welfare of communities. We sought to determine baseline opioid use in patients undergoing shoulder arthroplasty (SA) and identify patient characteristics, comorbidities, and surgical risk factors associated with postoperative opioid use.A Shoulder Arthroplasty Registry identified the number of dispensed opioid medication prescriptions (Rxs) in the first postoperative year in patients who underwent elective primary SA from 2008 to 2014. We used Poisson regression to study the effect of preoperative risks factors on number of dispensed opioid Rxs in the first postoperative year, evaluated quarterly (Q1: days 0-90, Q2: days 91-180, Q3: days 181-270, Q4: days 271-360).Included were 4243 SAs from 3996 patients, and 75% used opioids in the 1-year preoperative period. The factors associated with increased opioid use in all postoperative quarters (Q4 incident rate ratio [IRR] shown) were age60 years (IRR, 1.40; 95% confidence interval [CI], 1.29-1.51), preoperative opioid use (1-4 Rxs: IRR, 2.15; 95% CI, 1.85-2.51; ≥5 Rxs: IRR, 9.83; 95% CI , 8.53-11.32), anxiety (IRR, 1.11; 95% CI, 1.03-1.20), opioid dependence (IRR, 1.23; 95% CI, 1.05-1.43), substance abuse (IRR, 1.17; 95% CI, 1.07-1.28), and general chronic pain (IRR, 1.38; 95% CI, 1.28-1.50).Opioid usage in patients undergoing SA is widespread at 1 year, with three-fourths of patients having been dispensed at least one Rx. These findings emphasize the need for surgeon and patient awareness as well as education in the management of postoperative opioid usage associated with the indicated conditions. Surgeons may consider these risk factors for preoperative risk stratification and targeted deployment of preventative strategies.

Prior studies have documented racial and ethnic disparities in hip fracture treatment and outcome, and unequal access is commonly cited as a potential mediator. We sought to assess whether disparities in hip fracture outcome persist within a universally insured population of patients enrolled in a managed health-care system.A U.S. integrated health systems registry was used to identify patients who underwent treatment for a hip fracture when they were ≥60 years of age from 2009 to 2014. Patient demographics, procedure details, and outcomes were obtained from the registry. Differences in outcome according to race/ethnicity were analyzed using multivariable regression analysis with adjustment for socioeconomic status and other potential confounders.Of 17,790 patients, 79.4% were white, 3.9% were black, 9.4% were Hispanic, and 7.4% were Asian. Compared with white patients, black patients had a similar 1-year mortality rate (odds ratio [OR] = 0.93, 95% confidence interval [CI] = 0.79 to 1.09, p = 0.37), Hispanic patients had a lower rate (OR = 0.85, 95% = CI = 0.75 to 0.96, p = 0.01), and Asian patients also had a lower rate (OR = 0.65, 95% CI = 0.56 to 0.76, p0.001). There were no differences in terms of surgical delay, 90-day emergency department visits, or reoperations during the patient's lifetime (p0.05) between the groups. Compared with white patients, black and Hispanic patients had fewer 90-day postoperative complications (p = 0.04 and p = 0.01, respectively); 90-day unplanned readmissions were less common among Asian patients (p = 0.03) but more common among black patients (p = 0.01).In this study of hip fractures treated in an integrated managed care system, minority patients were found to have postoperative mortality rates that were similar to, or lower than, those of white patients. These findings may be related to the equal access and/or standardized protocols associated with treatment in this managed care system.Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background Prior studies have examined the relationship between surgeon and hospital volumes and outcome following hip fracture surgical procedures, but the results have been inconclusive. The purpose of this study was to assess the hip fracture volume-outcome relationship by analyzing data from a large, managed care registry. Methods The Kaiser Permanente Hip Fracture Registry prospectively records information on surgically treated hip fractures within the managed health-care system. Using this registry, all surgically treated hip fractures in patients 60 years of age or older were identified. Surgeon and hospital volume were defined as the number of hip fracture surgical procedures performed in the preceding 12 months and were divided into tertiles (low, medium, and high). The primary outcome was mortality at 1 year postoperatively. Secondary outcomes were mortality at 30 and 90 days postoperatively as well as reoperation (lifetime), medical complications (90-day), and unplanned readmission (30-day). To determine the relationship between volume and these outcome measures, multivariate logistic and Cox proportional hazards regression were performed, controlling for potentially confounding variables. Results Of 14,294 patients in the study sample, the majority were female (71%) and white (79%), and the mean age was 81 years. The overall mortality rate was 6% at 30 days, 11% at 90 days, and 21% at 1 year. We did not find an association between surgeon or hospital volume and mortality at 30 days, 90 days, or 1 year (p > 0.05). There was also no association between surgeon or hospital volume and reoperation, medical complications, or unplanned readmission (p > 0.05). Conclusions In this analysis of hip fractures treated in a large integrated health-care system, the observed rates of mortality, reoperation, medical complications, and unplanned readmission did not differ by surgeon or hospital volume. In contrast to other orthopaedic procedures, such as total joint arthroplasty, our data do not suggest that hip fractures need to be preferentially directed toward high-volume surgeons or hospitals for treatment. Level of evidence Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Background Use of the direct anterior approach (DAA) for total hip arthroplasty (THA) has increased over the last decade. We sought to investigate whether (1) a difference exists in dislocation risk for DAA compared with posterior THA, (2) a difference exists in risk for specific revision reasons, and (3) the likelihood of adverse 90-day postoperative events differs. Methods We conducted a cohort study using data from Kaiser Permanente’s Total Joint Replacement Registry. Patients aged ≥18 years who underwent primary cementless THA for osteoarthritis with a highly cross-linked polyethylene liner were included (2009-2017). Multivariable Cox proportional hazards regression was used to evaluate dislocation and cause-specific revision risks, and multivariable logistic regression was used to evaluate 90-day emergency department visits, 90-day unplanned readmissions, and 90-day complications (including deep infection, deep vein thrombosis, and pulmonary embolism). Results Of 38,399 primary THA, 6428 (16.7%) were DAA. All-cause revision at 2-years follow-up was 1.78% (95% confidence interval [CI] = 1.46-2.17) for DAA and 2.28% (95% CI = 2.11-2.45) for posterior. After adjusting for covariates, DAA had a lower risk of dislocation (hazard ratio [HR] = 0.39, 95% CI = 0.29-0.53), revision for instability (HR = 0.33, 95% CI = 0.18-0.58), revision for periprosthetic fracture (HR = 0.57, 95% CI = 0.34-0.96), and readmission (odds ratio = 0.82, 95% CI = 0.67-0.99) compared with posterior approach but a higher risk of revision for aseptic loosening (HR = 2.26, 95% CI = 1.35-3.79). Conclusion While the DAA associated with lower risks of dislocation and revision for instability and periprosthetic fracture, it is associated with a higher revision risk for aseptic loosening. Surgeons should discuss these risks with their patients.

Context Postmarket surveillance is limited in the ability to detect medical device problems. Electronic health records can provide real-time information that might help with device surveillance. Specifically, the frequency of postsurgery care might indicate early problems and determine high-risk patients requiring more active surveillance. Objective To evaluate whether intensity of postsurgery care is associated with revision risk after total joint arthroplasty (TJA). Design Using an integrated health care system's TJA registry, we identified primary TJA performed between April 2001 and July 2013 (22,953 knees and 9904 hips). Survival analyses evaluated the frequency of specific types of outpatient and inpatient utilization 0 to 90 and 91 to 180 days postoperatively and revision risk. Main outcome measures Revision surgery occurring at least 6 months after primary TJA. Results Knee arthroplasty recipients with 3 or more outpatient orthopedic allied health/nurse visits within 90 days had a 2.2 times (95% confidence interval [CI] = 1.6-2.9) higher risk of revision within the first 2 years postoperatively and 10.1 times higher risk (95% CI = 7.6-13.3) after 2 years. Compared with hip arthroplasty recipients who had 0 to 3 visits, patients with 6 or more outpatient orthopedic office visits within 90 days had a 15.7 times (95% CI = 5.7-42.9) higher risk of revision. Similar results were observed for 91-day to 180-day visits. Conclusion Future studies are needed to determine if more specific data on reasons for the higher frequency of outpatient visits can refine these findings and elicit more specific recommendations for TJA devices.

BACKGROUND: Opioid prescriptions following orthopaedic procedures may contribute to the opioid epidemic in the United States. Risk factors for greater and prolonged opioid utilization following total hip arthroplasty have yet to be fully elucidated. We sought to determine the prevalence of preoperative and postoperative opioid utilization in a cohort of patients who underwent total hip arthroplasty and to identify preoperative risk factors for prolonged utilization of opioids following total hip arthroplasty. METHODS: A cohort study of patients who underwent primary elective total hip arthroplasty at Kaiser Permanente from January 2008 to December 2011 was conducted. The number of opioid prescriptions dispensed per 90-day period after total hip arthroplasty (up to 1 year) was the outcome of interest. The risk factors evaluated included preoperative analgesic medication use, patient demographic characteristics, comorbidities, and other history of chronic pain. Poisson regression models were used, and relative risks (RRs) and 95% confidence intervals (CIs) are presented. RESULTS: Of the 12,560 patients who underwent total hip arthroplasty and were identified, 58.5% were female and 78.6% were white. The median age was 67 years (interquartile range, 59 to 75 years). Sixty-three percent of patients filled at least 1 opioid prescription in the 1 year prior to the total hip arthroplasty. Postoperative opioid use went from 88.6% in days 1 to 90 to 24% in the last quarter. An increasing number of preoperative opioid prescriptions was associated with a greater number of prescriptions over the entire postoperative period, with an RR of 1.10 (95% CI, 1.10 to 1.11) at days 271 to 360. Additional factors associated with greater utilization over the entire year included black race, chronic pulmonary disease, anxiety, substance abuse, and back pain. Factors associated with greater utilization in days 91 to 360 (beyond the early recovery phase) included female sex, higher body mass index, acquired immunodeficiency syndrome, peripheral vascular disease, and history of non-specific chronic pain. CONCLUSIONS: We identified preoperative factors associated with greater and prolonged opioid utilization long after the early recovery period following total hip arthroplasty. Patients with these risk factors may benefit from targeted multidisciplinary interventions to mitigate the risk of prolonged opioid use. CLINICAL RELEVANCE: Opioid prescriptions following orthopaedic procedures are one of the leading causes of chronic opioid use; strategies to reduce the risk of misuse and abuse are needed. At 1 year postoperatively, almost one-quarter of patients who underwent total hip arthroplasty used opioids in the last 90 days of the first postoperative year, which makes understanding risk factors associated with postoperative opioid utilization imperative. Refereed/Peer-reviewed

Background As total joint arthroplasty (TJA) utilization increases, arthroplasties of multiple joints in a patient are more common. An understanding of the success of shoulder arthroplasty patients also requiring a lower-extremity (hip or knee) TJA is lacking. We evaluated the following questions: (1) Is there a difference in the revision risk following shoulder arthroplasty in patients who also undergo a lower-extremity TJA compared with those who do not? (2) Does the revision risk differ depending on the sequence of the procedures? Methods Patients who underwent elective primary shoulder arthroplasty from 2009 through 2015 were identified using Kaiser Permanente's shoulder arthroplasty registry. Patients with a lower-extremity TJA were identified using the institution's total joint replacement registry. Revision related to the index shoulder was modeled via Cox regression stratified by procedure type and adjusted for confounders. Results Of the 4751 shoulder arthroplasties identified, 1285 (27.0%) underwent a prior hip and/or knee arthroplasty and 483 (10.2%) underwent a hip and/or knee arthroplasty following the index shoulder arthroplasty. No difference was found in all-cause shoulder revision risk with lower-extremity TJA before (hazard ratio, 1.38; 95% confidence interval, 0.97-1.96) or after (hazard ratio, 1.30; 95% confidence interval, 0.82-2.06) the index shoulder arthroplasty compared with patients who underwent a shoulder arthroplasty only. Conclusion In our study sample, we did not observe shoulder revision surgery risk to be different in patients who also underwent a lower-extremity TJA, regardless of the sequence of the 2 procedures. Future prospective studies should investigate whether the timing of the lower-extremity TJA in relation to the shoulder procedure impacts the latter's success.

Background and purpose — International comparisons of total hip arthroplasty (THA) practices and outcomes provide an opportunity to enhance the quality of care worldwide. We compared THA patients, implants, techniques, and survivorship in Sweden, Australia, and the United States. Patients and methods — Primary THAs due to osteoarthritis were identified using Swedish (n = 159,695), Australian (n = 279,693), and US registries (n = 69,641) (2003–2015). We compared patients, practices, and implant usage across the countries using descriptive statistics. We evaluated time to all-cause revision using Kaplan–Meier survival curves. We assessed differences in countries’ THA survival using chi-square tests of survival probabilities. Results — Sweden had fewer comorbidities than the United States and Australia. Cement fixation was used predominantly in Sweden and cementless in the United States and Australia. The direct anterior approach was used more frequently in the United States and Australia. Smaller head sizes (≤ 32 mm vs. ≥ 36 mm) were used more often in Sweden than the United States and Australia. Metal-on-highly cross-linked polyethylene was used more frequently in the United States and Australia than in Sweden. Sweden’s 5- (97.8%) and 10-year THA survival (95.8%) was higher than the United States’ (5-year: 97.0%; 10-year: 95.2%) and Australia (5-year: 96.3%; 10-year: 93.5%). Interpretation — Patient characteristics, surgical techniques, and implants differed across the 3 countries, emphasizing the need to adjust for demographics, surgical techniques, and implants and the need for global standardized definitions to compare THA survivorship internationally.

Background and purpose — The effect of total joint arthroplasty (TJA) on physical activity is not fully understood. We investigated the change in physical activity after TJA and patient factors associated with change. Patients and methods — Using a total joint replacement registry,primary total hip arthroplasty (THA) patients (n = 5,678) and knee arthroplasty (TKA) patients (n = 11,084) between January 1,2010 and December 31, 2012 were identified. Median age at THA was 68 and median age at TKA was 67. Change in self-reported physical activity (minutes per week) from before TJA (within 1year of surgery) to after TJA (1–2 years) was the outcome of interest.Patient demographics and comorbidities were evaluated as risk factors. Multiple linear regression was used. Results — Median physical activity before surgery was 50 min/week (IQR: 0–140) for THA patients and 58 (IQR: 3–143) for TKA patients. Median physical activity after surgery was 150 min/week (IQR: 60–280) for both THA patients and TKA patients. Following TJA, 50% of patients met CDC/WHO physical activity guideline criteria. Higher body mass index was associated with lower change in physical activity (THA: −7.1 min/week; TKA: −5.9 min/week). Females had lower change than males (THA: −11 min/week; TKA: −9.1 min/week). In TKA patients, renal failure was associated with lower change (−17 min/week), as were neurological disorders (−30 min/week). Interpretation — Self-reported minutes of physical activity increased from before to after TJA, but 50% of TJA patients did not meet recommended physical activity guideline criteria.Higher body mass index, female sex, and specific comorbidities were found to be associated with low change in physical activity.Patient education on the benefits of physical activity should concentrate on these subgroups of patients. Refereed/Peer-reviewed

OBJECTIVE Bone morphogenetic protein (BMP) was first approved in 2002 for use in single-level anterior lumbar fusions as an alternative to iliac crest grafts. Subsequent studies have concluded that BMP provides superior fusions rates and therefore reduces reoperations for nonunions. The purpose of this study was to determine the reoperation rates for symptomatic nonunions in posterior cervical (subaxial) spinal fusions with and without the use of BMP and to determine if the nonunion rates are statistically significantly different between the two groups. METHODS Between January 2009 and September 2013, the authors identified 1158 posterior cervical spinal fusion cases in the subaxial spine (C2–7) from a large spine registry (Kaiser Permanente). Patient characteristics, diagnoses, operative times, lengths of stay, and reoperations were extracted from the registry. Reoperations for symptomatic nonunions were adjudicated via chart review. Logistic regression was conducted to produce estimates of odds ratios (OR) and 95% confidence intervals (CIs). Kaplan-Meier curves for the non-BMP and BMP groups were generated and compared using the log-rank test. RESULTS In this cohort there were 1158 patients (19.3% with BMP) with a median follow up of 1.7 years (interquartile range [IQR] 0.7–2.9 years) and median duration to operative nonunion of 0.63 years (IQR 0.44–1.57 years). Kaplan-Meier curves showed no significant difference in reoperation rates for nonunions using the log-rank test (p = 0.179). In a subset of patients with more than 1 year of follow-up, 788 patients were identified (22.5% with BMP) with a median follow-up duration of 2.5 years (IQR 1.7–3.4 years) and a median time to operative nonunion of 0.73 years (IQR 0.44–1.57 years). There was no statistically significant difference in the symptomatic operative nonunion rates for posterior cervical (subaxial) fusions with BMP compared with non-BMP (1.1% vs 0.7%; crude OR 1.73, 95% CI 0.32–9.55, p = 0.527) for more than 1 year of follow-up. CONCLUSIONS This study presents the largest series of patients using BMP in posterior cervical (subaxial) spinal fusions. Reoperation rates for symptomatic nonunions with more than 1 year of follow-up were found to be 1.1% with BMP and 0.7% without BMP. There was no significant difference in the reoperation rates for symptomatic nonunions with or without BMP.

Importance Consensus guidelines and systematic reviews have suggested that cemented fixation is more effective than uncemented fixation in hemiarthroplasty for displaced femoral neck fractures. Given that these recommendations are based on research performed outside the United States, it is uncertain whether these findings also reflect the US experience. Objective To compare the outcomes associated with cemented vs uncemented hemiarthroplasty in a large US integrated health care system. Design, Setting, and Participants Retrospective cohort study of 12 491 patients aged 60 years and older who underwent hemiarthroplasty treatment of a hip fracture between 2009 and 2017 at 1 of the 36 hospitals owned by Kaiser Permanente, a large US health maintenance organization. Patients were followed up until membership termination, death, or the study end date of December 31, 2017. Exposures Hemiarthroplasty (prosthetic replacement of the femoral head) fixation via bony growth into a porous-coated implant (uncemented) or with cement. Main Outcomes and Measures The primary outcome measure was aseptic revision, defined as any reoperation performed after the index procedure involving exchange of the existing implant for reasons other than infection. Secondary outcomes were mortality (in-hospital, postdischarge, and overall), 90-day medical complications, 90-day emergency department visits, and 90-day unplanned readmissions. Results Among 12 491 patients in the study cohort who underwent hemiarthroplasty for hip fracture (median age, 83 years; 8660 women [69.3%]), 6042 (48.4%) had undergone uncemented fixation and 6449 (51.6%) had undergone cemented fixation, and the median length of follow-up was 3.8 years. In the multivariable regression analysis controlling for confounders, uncemented fixation was associated with a significantly higher risk of aseptic revision (cumulative incidence at 1 year after operation, 3.0% vs 1.3%; absolute difference, 1.7% [95% CI, 1.1%-2.2%]; hazard ratio [HR], 1.77 [95% CI, 1.43-2.19];P Conclusions and Relevance Among patients with hip fracture treated with hemiarthroplasty in a large US integrated health care system, uncemented fixation, compared with cemented fixation, was associated with a statistically significantly higher risk of aseptic revision. These findings suggest that US surgeons should consider cemented fixation in the hemiarthroplasty treatment of displaced femoral neck fractures in the absence of contraindications.

BACKGROUND: Both obesity and underweight are associated with a higher risk of mortality in adulthood, but the association between mortality after arthroplasty and extreme ranges of body mass index (BMI) have not been evaluated beyond the first year. QUESTIONS/PURPOSES: The purpose of this study was to investigate the association between BMI and all-cause mortality after TKA and THA. METHODS: Data from two arthroplasty registries, the St Vincent’s Melbourne Arthroplasty (SMART) Registry from Australia and the Kaiser Permanente Total Joint Replacement Registry (KPTJRR) from the United States, were used to identify patients aged ≥ 18 years undergoing elective TKAs and THAs between January 1, 2002, and December 31, 2013. Same-day bilateral THA and hemiarthroplasties were excluded. All-cause mortality was recorded from the day of surgery to the end of the study (December 31, 2013). Data capture was complete for the SMART Registry. No patients were lost to followup in the KPTJRR cohort and 2959 (5%) THAs and 5251 (5%) TKAs had missing data. Cox proportional hazard regression was used to estimate the all-cause mortality associated with six BMI categories: underweight (< 18.5 kg/m(2)), normal weight (18.5-24.9 kg/m(2)), overweight (25.0-29.9 kg/m(2)), obese class I (30.0-34.9 kg/m(2)), obese class II (35.0-39.9 kg/m(2)), and obese class III (> 40 kg/m(2)). For TKA, the SMART cohort had a median followup of 5 years (range, 0-12 years) and the KPTJRR cohort had a median followup of 4 years (range, 0-12 years). For THA, the SMART cohort had a median followup of 5 years (range, 0-12 years) and the KPTJRR cohort had a median followup of 4 years (range, 0-12 years). RESULTS: In both the Australian and US cohorts, being underweight (Australia: hazard ratio [HR], 3.72; 95% confidence interval [CI], 1.94-7.08; p < 0.001 and United States: HR, 1.88; 95% CI, 1.33-2.64; p < 0.001) was associated with higher all-cause mortality after TKA, whereas obese class I (Australia: HR, 0.66; 95% CI, 0.47-0.92; p = 0.015; United States: HR, 0.71; 95% CI, 0.66-0.78; p < 0.001) or obese class II (Australia: HR, 0.54; 95% CI, 0.35-0.82; p = 0.004; United States: HR, 0.73; 95% CI, 0.66-0.81; p < 0.001) was associated with lower mortality when compared with normal-weight patients. In the US cohort, being overweight was also associated with a lower risk of mortality (HR, 0.76; 95% CI, 0.71-0.82; p < 0.001). In the US cohort, being underweight had a higher risk of mortality after THA (HR, 2.09; 95% CI, 1.65-2.64; p < 0.001), whereas those overweight (HR, 0.73; 95% CI, 0.67-0.80; p < 0.001), obese class I (HR, 0.68; 95% CI, 0.62-0.75; p < 0.001), or obese class II (HR, 0.71; 95% CI, 0.62-0.81; p < 0.001) were at a lower risk of mortality after THA when compared with normal-weight patients. In patients undergoing THA in the Australian cohort, we observed no association between BMI and risk of death. CONCLUSIONS: We found that even severe obesity is not associated with a higher risk of death after arthroplasty. Patients should be informed of this when considering surgery. Clinicians should be cautious when considering total joint arthroplasty in underweight patients without first considering their nutritional status. LEVEL OF EVIDENCE: Level III, therapeutic study.

Background and purpose: Although common in medical research, meta-analysis has not been widely adopted in registry collaborations. A meta-analytic approach in which each registry conducts a standardized analysis on its own data followed by a meta-analysis to calculate a weighted average of the estimates allows collaboration without sharing patient-level data. The value of meta-analysis as an alternative to individual patient data analysis is illustrated in this study by comparing the risk of revision of porous tantalum cups versus other uncemented cups in primary total hip arthroplasties from Sweden, Australia, and a US registry (2003-2015). Patients and methods - For both individual patient data analysis and meta-analysis approaches a Cox proportional hazard model was fit for time to revision, comparing porous tantalum (n = 23,201) with other uncemented cups (n = 128,321). Covariates included age, sex, diagnosis, head size, and stem fixation. In the meta-analysis approach, treatment effect size (i.e., Cox model hazard ratio) was calculated within each registry and a weighted average for the individual registries' estimates was calculated. Results - Patient-level data analysis and meta-analytic approaches yielded the same results with the porous tantalum cups having a higher risk of revision than other uncemented cups (HR (95% CI) 1.6 (1.4-1.7) and HR (95% CI) 1.5 (1.4-1.7), respectively). Adding the US cohort to the meta-analysis led to greater generalizability, increased precision of the treatment effect, and similar findings (HR (95% CI) 1.6 (1.4-1.7)) with increased risk of porous tantalum cups. Interpretation - The meta-analytic technique is a viable option to address privacy, security, and data ownership concerns allowing more expansive registry collaboration, greater generalizability, and increased precision of treatment effects. Refereed/Peer-reviewed

Lack of consensus continues regarding the benefit of anteriorly based surgical approaches for primary total hip arthroplasty (THA). The purpose of this study was to evaluate the risk of aseptic revision, septic revision, and dislocations for various approaches used in primary THAs from a community-based healthcare organization.(1) What is the incidence of aseptic revision, septic revision, and dislocation for primary THA in a large community-based healthcare organization? (2) Does the risk of aseptic revision, septic revision, and dislocation vary by THA surgical approach?The Kaiser Permanente Total Joint Replacement Registry was used to identify primary THAs performed between April 1, 2001 and December 31, 2011. Endpoints were septic revisions, aseptic revisions, and dislocations. The exposure of interest was surgical approach (posterior, anterolateral, direct lateral, direct anterior). Patient, implant, surgeon, and hospital factors were evaluated as possible confounders. Survival analysis was performed with marginal multivariate Cox models. Hazard ratios (HRs) and 95% confidence intervals (CIs) are reported. A total of 42,438 primary THAs were available for analysis of revision outcomes and 22,237 for dislocation. Median followup was 3 years (interquartile range, 1-5 years). The registry's voluntary participation is 95%. The most commonly used approach was posterior (75%, N = 31,747) followed by anterolateral (10%, N = 4226), direct anterior (4%, N = 1851), and direct lateral (2%, N = 667).During the study period 785 hips (2%) were revised for aseptic reasons, 213 (0.5%) for septic reasons, and 276 (1%) experienced a dislocation. The revision rate per 100 years of observation was 0.54 for aseptic revisions, 0.15 for septic revisions, and 0.58 for dislocations. There were no differences in adjusted risk of revision (either septic or aseptic) across the different THA approaches. However, the anterolateral approach (adjusted HR, 0.29; 95% CI, 0.13-0.63, p = 0.002) and direct anterior approach (adjusted HR, 0.44; 95% CI, 0.22-0.87, p = 0.017) had a lower risk of dislocation relative to the posterior approach. There were no differences in any of the outcomes when comparing the direct anterior approach with the anterolateral approach.Anterior and anterolateral surgical approaches had the advantage of a lower risk of dislocation without increasing the risk of early revision.Level III, therapeutic study.

BackgroundAlthough total hip arthroplasty (THA) is a successful procedure, 4% to 11% of patients who undergo THA are readmitted to the hospital. Prior studies have reported rates and risk factors of THA readmission but have been limited to single-center samples, administrative claims data, or Medicare patients. As a result, hospital readmission risk factors for a large proportion of patients undergoing THA are not fully understood.Questions/purposes(1) What is the incidence of hospital readmissions after primary THA and the reasons for readmission? (2) What are the risk factors for hospital readmissions in a large, integrated healthcare system using current perioperative care protocols?MethodsThe Kaiser Permanente (KP) Total Joint Replacement Registry (TJRR) was used to identify all patients with primary unilateral THAs registered between January 1, 2009, and December 31, 2011. The KPTJRR's voluntary participation is 95%. A logistic regression model was used to study the relationship of risk factors (including patient, clinical, and system-related) and the likelihood of 30-day readmission. Readmissions were identified using electronic health and claims records to capture readmissions within and outside the system. Odds ratio (OR) and 95% confidence intervals (CIs) were calculated. Of the 12,030 patients undergoing primary THAs included in the study, 59% (n = 7093) were women and average patient age was 66.5 years (± 10.7).ResultsThere were 436 (3.6%) patients with hospital readmissions within 30 days of the index procedure. The most common reasons for readmission were infection and inflammatory reaction resulting from internal joint prosthetic (International Classification of Diseases, 9(th) Revision, Clinical Modification [ICD-9-CM] 996.66, 7.0%); other postoperative infection (ICD-9-CM 998:59, 5.5%); unspecified septicemia (ICD-9-CM 038.9, 4.9%); and dislocation of a prosthetic joint (ICD-9-CM 996.42, 4.7%). In adjusted models, the following factors were associated with an increased likelihood of 30-day readmission: medical complications (OR, 2.80; 95% CI, 1.59-4.93); discharge to facilities other than home (OR, 1.89; 95% CI, 1.39-2.58); length of stay of 5 or more days (OR, 1.80; 95% CI, 1.22-2.65) versus 3 days; morbid obesity (OR, 1.74; 95% CI, 1.25-2.43); surgeries performed by high-volume surgeons compared with medium volume (OR, 1.53; 95% CI, 1.14-2.08); procedures at lower-volume (OR, 1.41; 95% CI, 1.07-1.85) and medium-volume hospitals (OR, 1.81; 95% CI, 1.20-2.72) compared with high-volume ones; sex (men: OR, 1.51; 95% CI, 1.18-1.92); obesity (OR, 1.32; 95% CI, 1.02-1.72); race (black: OR, 1.26; 95% CI, 1.02-1.57); increasing age (OR, 1.03; 95% CI, 1.01-1.04); and certain comorbidities (pulmonary circulation disease, chronic pulmonary disease, hypothyroidism, and psychoses).ConclusionsThe 30-day hospital readmission rate after primary THA was 3.6%. Modifiable factors, including obesity, comorbidities, medical complications, and system-related factors (hospital), have the potential to be addressed by improving the health of patients before this elective procedure, patient and family education and planning, and with the development of high-volume centers of excellence. Nonmodifiable factors such as age, sex, and race can be used to establish patient and family expectations regarding risk of readmission after THA. Contrary to other studies and the finding of increased hospital volume associated with lower risk of readmission, higher volume surgeons had a higher risk of patient readmission, which may be attributable to the referral patterns in our organization.Level of evidenceLevel III, therapeutic study.

Background and purpose — Aseptic revisions comprise 80% of revision total knee arthroplasties (TKAs). We determined the incidence of re-revision TKA, the reasons for re-revision, and risk factors associated with these procedures. Patients and methods — We conducted a retrospective cohort study of 1,154 patients who underwent aseptic revision TKA between 2002 and 2013 and were followed prospectively by a total joint replacement registry in the USA. Revision was defined as any operation in which an implanted component was replaced. Patient-, surgeon-, and procedure-related risk factors were evaluated. Survival analyses were conducted. Results — There were 114 re-revisions (10%) with a median time to reoperation of 3.6 years (interquartile range (IQR): 2.6–5.2). The infection rate was 2.9% (34/1,154) and accounted for 30% of re-revisions (34 of 114). In adjusted models, use of antibiotic-loaded cement was associated with a 50% lower risk of all-cause re-revision surgery (hazard ratio (HR) = 0.5, 95% CI: 0.3–0.9), age with a 20% lower risk for every 10-year increase (HR = 0.8, CI: 0.7–1.0), body mass index (BMI) with a 20% lower risk for every 5-unit increase (HR = 0.8, CI: 0.7–1.0), and a surgeon’s greater cumulative experience (≥ 20 cases vs.